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Effects of Ciprofol Anesthesia on Learning and Memory Function and Antidepressant Effects of ECT in Depressive Patients

Primary Purpose

Depressive Disorder

Status

Not yet recruiting

Phase

Early Phase 1

Locations

Study Type

Interventional

Intervention

ciprofol

Propofol

About this trial

This is an interventional prevention trial for Depressive Disorder

Eligibility Criteria

16 Years - 45 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Depressed patients who plan to receive MECT.
Meet the diagnostic criteria of DSM-IV depression
16≤age≤45 years old, gender is not limited
ASA score is I or II
The depressive episode lasted for at least 2 weeks
Clearly understand and voluntarily participate in the study and sign the informed consent form.

Exclusion Criteria:

Combined with serious physical diseases, such as uncontrolled hypertension, coronary heart disease, intracranial vascular malformations, asthma attacks, severe liver and kidney dysfunction, etc.
Foreign bodies in the body: such as pacemakers, intracranial electrodes, etc.
Those who have a history of epilepsy
Those who are taking reserpine
Those with acute and systemic infectious diseases, with moderate or higher fever
Those with a history of manic episodes
Those with anesthetics, Allergic to muscle relaxants
Pregnant women
Glaucoma
Bipolar disorder, or combined with other mental illnesses, mental retardation
Those who are judged not suitable for MECT treatment by the competent physician
History of drug abuse

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Propofol injection group (1.5mg/kg)

Ciprofol injection group(0.4mg/kg)

Arm Description

The patients in the propofol group were given intravenous injection of propofol 1.5 mg/kg and succinylcholine 1 mg/kg in turn, and the interval between each drug administration was 1 minute, and electroconvulsive therapy was performed after the patients were anesthetized.

The patients in the ciprofol group were given intravenous injection of ciprofol 0.4 mg/kg and succinylcholine 1 mg/kg in turn. The interval between each drug administration was 1 minute, and the patients received electroconvulsive therapy after anesthesia.

Outcomes

Primary Outcome Measures

Cognitive impairment rate within 24 hours after the whole ECT course

Percentage of patients with cognitive impairment within 24 hours after the whole ECT course

Secondary Outcome Measures

Full Information

NCT ID

NCT05266560

First Posted

February 14, 2022

Last Updated

March 3, 2022

Sponsor

First Affiliated Hospital of Chongqing Medical University

1. Study Identification

Unique Protocol Identification Number

NCT05266560

Brief Title

Effects of Ciprofol Anesthesia on Learning and Memory Function and Antidepressant Effects of ECT in Depressive Patients

Official Title

Effects of Ciprofol Anesthesia on Learning and Memory Function and Antidepressant Efficacy of ECT in Patients With Depression

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

March 1, 2022 (Anticipated)

Primary Completion Date

July 1, 2024 (Anticipated)

Study Completion Date

December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

First Affiliated Hospital of Chongqing Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

In this clinical study, propofol was used as the positive control, and a randomized controlled trial design was used to observe the effects of ciprofol anesthesia on learning and memory function and antidepressant efficacy in patients with ECT. A total of 390 depressed patients who were to undergo electroconvulsive therapy were selected and randomly divided into two groups, namely the propofol group (n=195 cases) and the ciprofol group (n=195 cases). The patients in the propofol group were given propofol 1.5mg/kg + succinylcholine 1mg/kg, and the patients in the ciprofol group were given ciprofol 0.4mg/kg and succinylcholine 1mg/kg, and the patients were given electroshock after anesthesia treat.

Detailed Description

Ciprofol injection, whose active component (HSK3486) is propofol analogue, is a novel treatment for anesthesia induction and maintenance. It has been authorized for commercialization in China on December 14, 2020. The purpose of this experiment is to know the effect of ciprofol on the antidepressant effect and cognitive function of depressive patients after electroconvulsive therapy. Ciprofol is very similar in structure to propofol, so propofol was used as the control group in this experiment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Depressive Disorder

7. Study Design

Primary Purpose

Prevention

Study Phase

Early Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

390 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Propofol injection group (1.5mg/kg)

Arm Type

Active Comparator

Arm Description

Arm Title

Ciprofol injection group(0.4mg/kg)

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

ciprofol

Other Intervention Name(s)

2-[(1R)-1-cyclopropylethyl]-6-isopropyl-phenol

Intervention Description

A new type of anesthetic drug, Ciprofol, which is newly listed and has national independent intellectual property rights, is an analogue of propofol. Its chemical name is 2-[(1R)-1-cyclopropylethyl]-6-isopropyl-phenol, and it acts on GABAA receptors like propofol. Compared with propofol, ciprofol is 4-5 times more potent, which can significantly reduce the amount of anesthetics.

Intervention Type

Drug

Intervention Name(s)

Propofol

Other Intervention Name(s)

2,6-Diisopropylphenol

Intervention Description

Propofol is a commonly used anesthetic in clinical practice and is often used before ECT.

Primary Outcome Measure Information:

Title

Cognitive impairment rate within 24 hours after the whole ECT course

Description

Percentage of patients with cognitive impairment within 24 hours after the whole ECT course

Time Frame

After the patient received MECT treatment within 24 hours after the whole ECT course

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Depressed patients who plan to receive MECT. Meet the diagnostic criteria of DSM-IV depression 16≤age≤45 years old, gender is not limited ASA score is I or II The depressive episode lasted for at least 2 weeks Clearly understand and voluntarily participate in the study and sign the informed consent form. Exclusion Criteria: Combined with serious physical diseases, such as uncontrolled hypertension, coronary heart disease, intracranial vascular malformations, asthma attacks, severe liver and kidney dysfunction, etc. Foreign bodies in the body: such as pacemakers, intracranial electrodes, etc. Those who have a history of epilepsy Those who are taking reserpine Those with acute and systemic infectious diseases, with moderate or higher fever Those with a history of manic episodes Those with anesthetics, Allergic to muscle relaxants Pregnant women Glaucoma Bipolar disorder, or combined with other mental illnesses, mental retardation Those who are judged not suitable for MECT treatment by the competent physician History of drug abuse

12. IPD Sharing Statement

Learn more about this trial

Effects of Ciprofol Anesthesia on Learning and Memory Function and Antidepressant Effects of ECT in Depressive Patients

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